ICSI Versus Conventional IVF in Couples With Unexplained Infertility
NCT ID: NCT07294027
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
848 participants
INTERVENTIONAL
2026-01-01
2028-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
However, the doctors performing embryo transfers, medical staff conducting routine prenatal check-ups and laboratory technicians analyzing biological samples will not be directly informed of whether patients participate in this clinical study and their grouping status.
Study Groups
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Intracytoplasmic Sperm Injection (ICSI)
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo ICSI procedure according to the result of randomization.
The first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. The remaining available embryos will be frozen.
ICSI
Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection.
Other standard assisted reproductive treatments are similar and parallel between two groups.
Conventional in vitro fertilization (c-IVF)
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo conventional IVF procedure according to the result of randomization.
The first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. If the embryos in the IVF group are fertilized through different methods (some with late-RICSI), the first embryo transfer is limited to embryos fertilized through conventional IVF. The remaining available embryos will be frozen.
IVF
Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm/ml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination.
If the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The injection method is same as standard ICSI.
Other standard assisted reproductive treatments are similar and parallel between two groups.
Interventions
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ICSI
Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection.
Other standard assisted reproductive treatments are similar and parallel between two groups.
IVF
Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm/ml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination.
If the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The injection method is same as standard ICSI.
Other standard assisted reproductive treatments are similar and parallel between two groups.
Eligibility Criteria
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Inclusion Criteria
2. 18.5 \< BMI \< 24kg/m2
3. Couples diagnosed with primary unexplained infertility:
* Regular menses or confirmed ovulation;
* Normal ovarian reserve;
* Patent fallopian tubes;
* Normal uterus and cervix;
* Normal endocrine profile;
* Semen analysis meeting WHO 6th edition criteria
* Normal karyotypes in both partners, no family history of genetic disorders
4. First IVF/ICSI cycle
5. Received GnRH agonist protocol or GnRH antagonist protocol
6. Willing to provide informed consent and comply with follow-up
Exclusion Criteria
2. In vitro maturation (IVM) cycles
3. Using donor sperm/oocyte
4. Using frozen sperm/oocyte
5. \<5 oocytes retrieved
6. Abnormal semen parameters on the day of oocyte retrieval
7. High risk of tubal pathology or endometriosis without laparoscopic exclusion
8. Untreated or poorly controlled endocrine disorders
9. Abnormal immune related examinations
10. Major organ/system disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)
11. Concurrent participation in other clinical trials.
20 Years
38 Years
FEMALE
No
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Jiaxing Maternity and Child Health Care Hospital
OTHER
Ningbo Women & Children's Hospital
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Xiangyang Central Hospital
OTHER
Huangshi Central Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Min Jin, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Huangshi Central Hospital
Huangshi, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Jiaxing Maternity and Child Health Care Hospital
Jiaxing, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaokui Yang
Role: primary
Junling Wang
Role: primary
Qingzhen Xie
Role: primary
Xuezhou Yang
Role: primary
Min Jin
Role: primary
Weiping Fu
Role: primary
Liming Zhou
Role: primary
Other Identifiers
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2025-0689
Identifier Type: -
Identifier Source: org_study_id